Model Number N/A |
Device Problem
Migration (4003)
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Patient Problem
Pain (1994)
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Event Date 10/13/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item number p0463044 item name avan cmntd shell ss 44mm lot # 0000710631.Item number p0560044 item name avan insert 44/22 lot # 0000714004.Item number 163651 item name 22.2mm dia cocr mod hd std nk lot # 428170.Foreign report source: (b)(6).The device will not be returned for analysis, due to hospital policy; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03916.0001825034 - 2020 - 03920.0001825034 - 2020 - 03922.0001825034 - 2020 - 03923.
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Event Description
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It was reported patient underwent hip arthroplasty.Subsequently, patient was revised approximately 8 years later due to hip pain.Surgeon had xrays taken and showed movement of the cup and cage.Surgeon operated to remove cup and cage.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: advanced osteolysis of the right hip arthroplasty as noted with suspected loosening of the acetabular implant.A review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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